Worst Case Consideration, page-5

Risks are being reduced day by day. We aren’t privy to what is going on in the background.

People have raised concerns about PR, but IMHO he has got us to where we are today. Will we ever know why Marco left, probably not.

People raised concerns about trial delays and all of a sudden we get Fast Track Designation.

We have positive data out of 008 and the data showed statistical meaningful change for a trial that was powered to show a meaningful change.

we have had a look through into the likely results from the NFL players.
We have heard amazing experiences and outcomes from people on HC.
We have phase 2b trial results and many treated on SAS without serious AE.

What is the risk that we don’t meet the FDA’s standard for approval? What is the likelihood that we will gain DMOAD?

What are the odds that something left field comes out of nowhere to further reduce our risks eg Accelerated Approval or a deal for MPS or OA. Or even something that hasn’t even been thought of yet happens to further de risk PAR.

what risks are left:
Fail primary end point.
supply chain / vendor risk.
New product that comes to market or substitute

the risk of the unknown knowns is always present until we get approved. The question is what is an individual’s own risk tolerance?

IMO and I am no Dr or scientist. But I personally believe we are like Winx at $1.02 odds on to get past the post first. I am in the queue waiting to get paid. Or waiting to hear that FB has cracked open a case of Grange